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FDA 510(k)

BSM 2000 DIALYSIS MACHINE - MODIFIED

K-Number: K850569 · 1985-03-12

ApplicantOrganon Teknika Corp.
Decision Date1985-03-12
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BSM 2000 DIALYSIS MACHINE - MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K850569. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BSM 2000 DIALYSIS MACHINE - MODIFIED?

BSM 2000 DIALYSIS MACHINE - MODIFIED is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Organon Teknika Corp.. The 510(k) number is K850569.

When did BSM 2000 DIALYSIS MACHINE - MODIFIED receive FDA 510(k) clearance?

BSM 2000 DIALYSIS MACHINE - MODIFIED received FDA 510(k) clearance on 1985-03-12, under 510(k) number K850569.

Who is the listed applicant for BSM 2000 DIALYSIS MACHINE - MODIFIED?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BSM 2000 DIALYSIS MACHINE - MODIFIED?

The FDA product code for BSM 2000 DIALYSIS MACHINE - MODIFIED is FKP.

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Other records listing Organon Teknika Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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Related Devices (Code: FKP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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